| January 27, 2009 |
| September 14, 2009 |
| April 2009 |
| July 2010 (final data collection date for primary outcome measure) |
| LUTS relief based on reduction in IPSS (questionnaire) [ Time Frame: After 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00831233 on ClinicalTrials.gov Archive Site |
- LUTS relief based on reduction in IPSS (questionnaire) [ Time Frame: After treatment of 4 and 8 weeks compared to Baseline ] [ Designated as safety issue: No ]
- LUTS relief based on maximum urine flow (Qmax) and residual volume (Vresidual) [ Time Frame: After treatment of 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
- Prostate size reduction based on Trans Rectal Ultra Sound (TRUS) [ Time Frame: After 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]
- Time to removal of urethral catheter [ Time Frame: As applicable ] [ Designated as safety issue: No ]
- Change in Testosterone serum concentration [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
- Change in PSA concentration [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
- Quality of Life evaluation based on questionnaire [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
- Safety (Adverse events and lab values) [ Time Frame: As applicable ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer |
| A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer |
The purpose of this trial is to see how well a new trial drug (Degarelix) works on symptoms in the lower urinary tract in prostate cancer patients as compared to how a standard drug hormonal treatment works on the same symptoms. The lower urinary tract symptoms (also known as LUTS) are associated with the advancement/worsening of prostate cancer, and the symptoms impact the ability to urinate normally and thereby the quality of life for these patients. Patients will be randomly selected (like flipping a coin) to receive either Degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms will be evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Prostate Cancer |
- Drug: Degarelix
- Drug: Goserelin
|
- Experimental: Drug: Degarelix
- Active Comparator: Drug: Goserelin (Zoladex®) combined with anti-androgen flare protection bicalutamide (Casodex®)
|
| |
| |
| Recruiting |
| 280 |
| October 2010 |
| July 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patient has given written informed consent before any trial-related activity is performed
- Has a confirmed prostate cancer in which this type of treatment is needed.
Exclusion Criteria:
- Previous treatment for prostate cancer
- Previous trans-urethral resection of the prostate
- Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
- Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
- History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Hypersensitivity towards any component of the investigational product
- Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
- Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.
|
| Male |
| 18 Years and older |
| No |
|
|
| Germany, Spain, United Kingdom |
| |
| NCT00831233 |
| Hjort, Director, Ferring Pharmaceuticals |
| FE200486 CS28, 2008-004338-26 (EudraCT No) |
| Ferring Pharmaceuticals |
|
| Study Director: |
Clinical Development Support |
Ferring Pharmaceuticals |
|
|
| Ferring Pharmaceuticals |
| September 2009 |